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SERM Medical Director, Oncology

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OverviewThis job is with GSK, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Job PurposeProvides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting. Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks. Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally. If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors. Line Management (including functional matrix reports) leadership competencies include resource and team management, coaching, influencing others, collaborative working, decision making, change management, partnership, and relations management.

Key ResponsibilitiesScientific/Medical Knowledge PV Expertise

Leads Pharmacovigilance and Risk Management Planning and develops strategy for approach to evaluation of issues in the clinical matrix.

Leads the safety component of global regulatory submissions.

Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis and interpretation.

Demonstrated track record of quality decision making and creative problem resolution, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context.

Demonstrates highly developed multi-tasking skills, ability to prioritise tasks and consistently delivers on deadlines, with high performance standards for quality.

Explores positions and alternatives to reach mutually beneficial agreements and solutions.

Cross-functional Matrix team leadership

Leads safety governance by development of safety strategy and its execution for products in clinical development and post marketing settings. Anticipates, detects and addresses product safety issues and ensures that risk-reduction strategies are implemented appropriately.

Facilitates safety governance/SRTs in the clinical development and post marketing settings by assisting in the establishment and operation of cross-functional teams to detect and address product safety issues and ensures that risk-reduction strategies are implemented appropriately in clinical study protocols and/or product labelling.

Represents GS on cross-functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues.

Leads or participates in cross-functional process initiatives and/or Process Workstreams to drive efforts to improve adherence to regulations, data standards, quality and efficiency.

Authors/participates in written standard updates (e.g., SOPs) to ensure policies and regulations are being adhered to correctly and consistently.

Accountable for the escalation of issues and communication on safety matters. Builds strong working relationships and displays leadership on safety issues while working in a matrix setting; ability to coach and mentor others.

Communications and Influencing

Leads presentations on recommendations or safety issues to senior staff members at the GSK Senior Governance Committees. Interacts with confidence, credibility, and influence at all levels of the GSK organization and represents GSK in safety discussions with regulatory authorities, outside consultants and licensing partners.

Leads cross-functional process improvement teams within GSK. Considers internal and external environments when addressing safety issues and changes to SERM processes or business improvements. Contributes to long-term strategy for clinical programs and brings innovative ideas to address new issues.

Leads inspection readiness and is prepared to support audits/inspections. Excellent communication and influencing skills both internally and externally.

Why you?Basic QualificationsWe are looking for professionals with these required skills to achieve our goals:

Primary medical qualification (MBBS or equivalent) and completion of Specialty training (CCT and fellowship or equivalent level).

Experience, at least, within a Clinical background/setting.

Experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS initiatives) and drug development and approval processes.

Preferred Qualifications

PhD/PharmD or MPH in addition to medical degree and registration/certification.

Why GSK?GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We strive to create an environment where people can thrive and deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer and supports an agile working culture.

Important noticesGSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under law. For adjustments to our process, contact UKRecruitment.Adjustments@gsk.com or 0808 234 4391. If your enquiry does not relate to adjustments, other channels may apply. See UK Recruitment FAQ for more information.

Seniority levelDirector

Employment typeFull-time

Job functionHealth Care ProviderIndustries: Pharmaceutical Manufacturing

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